Off-Label Promotion Gets Political Support But Is It Good For Consumers? 

On 21 March 2017, the State of Arizona became the first state to pass the “Free Speech in Medicine Act” which allows manufacturers to practically discuss all kinds of off-label information with doctors and healthcare providers, without fear of prosecution. The day after, a similar bill, “Medical Product Communications Act, 2017”, was introduced in the US Congress. These laws in effect expand on the US court rulings in the recent years that allowed manufacturers to discuss certain kinds of off-label information for commercial purposes. It should be noted that while these laws purport to give the manufacturers “free speech” rights regarding their products, their main goal is to reduce FDA’s mandate for regulation of advertisement. These laws effectively encourage manufacturers to go around FDA review of new uses of previously approved products. FDA allows distribution of off-label information provided it is truthful, unbiased and non-commercial. Multiple FDA guidance documents clarify what kinds of off-label information can be shared and how. Peer-reviewed, scientific information can be shared but anecdotal non-peer-reviewed information cannot be shared. The new laws allow sharing of non-peer reviewed information such as letters to editors, presentations at conferences, documents prepared by the employees of manufactures about their own research efforts, and health economic information. Manufacturers will be required to assure that the information shared be truthful and contain disclaimers that the said information is not reviewed by FDA but that’s not sufficient. There are several concerns with this proposal. First, peer-review assures relatively unbiased independent review of scientific information. By allowing new information that has neither been reviewed by FDA or the scientific peers, the laws creates a loop hole for manufacturers to use unreliable and biased information for marketing. Second, since the manufacturers are allowed to commercially use practically all new information in support of marketing activities, there is little incentive to formally submit such information to FDA making it hard for FDA to investigate and manage adverse events related to such new uses. Third, since much of such non-peer reviewed new use information may be of proprietary nature, manufacturers will prefer to not amend their FDA-approved label and no public disclosure, making it hard for generic versions of their products to claim similar uses. Finally, although the proposed law requires that the new information be truthful, it does not define “truthful information”. Information can be incomplete or one-sided and still be truthful in one’s judgment. The burden to prove that the given information is incomplete or misleading shifts from the manufacturer to the regulators making it harder to regulate such information. In all, such provisions create greater risk for consumers. Currently, doctors can prescribe products for off-label uses but do so based on their own experience and at their own risk. This law, if passed, would lead to more off-label prescriptions by legalizing a risky practice. FDA review of all information related to prescription products before commercial use protects patients. Let’s not dilute that.